Hansa Biopharma Completes Phase 3 US ConfIdeS Trial Randomization

Hansa Biopharma AB, a prominent biopharmaceutical company based in Lund, Sweden, announced that it has completed the recruitment and randomization phase of its critical Phase 3 ConfIdeS trial in the United States. This open-label, randomized, controlled study focuses on assessing the effectiveness of imlifidase in kidney transplantation. The results from this trial are anticipated to support Hansa's Biologic License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway, expected in the latter half of 2025.

The ConfIdeS trial involves 64 highly sensitized kidney transplant patients, defined by a calculated panel reactive antibody (cPRA) of 99.9% or higher, who have a positive crossmatch against a deceased donor. These patients are divided into two groups: those receiving desensitization treatment with imlifidase and those receiving the standard care. The primary objective of the trial is to evaluate kidney graft function at the 12-month mark, measured by the estimated Glomerular Filtration Rate (eGFR). The trial is conducted across 24 sites in the United States.

Søren Tulstrup, President and CEO of Hansa Biopharma, remarked on the significance of the milestone, emphasizing the potential of imlifidase to address the substantial unmet needs of highly sensitized kidney transplant patients in the U.S. Tulstrup expressed optimism that the trial would further substantiate imlifidase's role as a vital desensitization treatment, facilitating HLA-incompatible kidney transplants. He noted that the company looks forward to presenting the trial data in the future.

Imlifidase, marketed under the name IDEFIRIX® in Europe, has received conditional marketing approval for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against a deceased donor. Besides kidney transplantation, imlifidase is being explored for its potential applications in treating autoimmune conditions like anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barré syndrome (GBS), as well as a pre-treatment in gene therapy for patients with rare diseases who have pre-existing antibodies.

Highly sensitized patients, who possess pre-formed antibodies known as donor specific antibodies (DSAs) that react broadly against human leukocyte antigens (HLAs), face significant challenges in finding compatible donors due to the risk of tissue damage and transplant rejection. These patients often spend more time on transplant waiting lists, which correlates with an increased mortality risk. In the U.S. and Europe, approximately 10-15% of transplant waiting list patients are highly sensitized.

Imlifidase works by targeting and cleaving immunoglobulin G (IgG) antibodies, quickly inhibiting their immune response within hours. This rapid action provides a critical window for transplantation before the body can regenerate new IgG, during which the patient starts post-transplant immunosuppressive therapy to prevent organ rejection. The efficacy and safety of imlifidase as a pre-transplant treatment have been supported by four Phase 2 open-label clinical trials.

Kidney failure, or End-Stage Renal Disease (ESRD), occurs when kidney function drops below 15%. Affecting nearly 2.5 million people globally, ESRD poses a significant health burden. Kidney transplantation is the preferred treatment for suitable ESRD patients due to its survival and quality-of-life benefits, as well as cost savings compared to long-term dialysis. There are approximately 170,000 patients on kidney transplant waiting lists across the U.S., European Union, and United Kingdom.

Hansa Biopharma is committed to developing groundbreaking treatments for patients with rare immunological conditions. The company has pioneered an IgG antibody-cleaving enzyme therapy platform, with ongoing research and development efforts aimed at addressing unmet needs in transplantation, autoimmune diseases, gene therapy, and cancer. Hansa Biopharma is listed on Nasdaq Stockholm under the ticker HNSA.